[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lei Li\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,70,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100558963","cervical-cytology-dna-methylation-for-cervical-cancer-screening-100558963",false,"NCT06557954","Cervical Cytology DNA Methylation for Cervical Cancer Screening","Cervical Cytology DNA Methylation for Cervical Cancer Screening: A Real Word Study","Inclusion Criteria:\n\n* Aged 18 years or older\n* With uterine cervix intact\n* Given consents to participate the study\n* With detailed follow-up outcomes\n\nExclusion Criteria:\n\n* Not meeting all of the inclusion criteria","FEMALE","18 Years",{"count":19,"type":20},30000,"ESTIMATED","OBSERVATIONAL","Cervical cancer represents one of the foremost causes of cancer-related morbidity and mortality among women worldwide. Given the current limitations, such as the low specificity of human papillomavirus (HPV) testing and the relatively low sensitivity of cytological examinations, there is a pressing need for a novel, non-invasive, safe, and precise screening method. This study aims to undertake a multicentre, real-world investigation, incorporating at least 10 sub-centres and enrolling 30,000 participants. Histopathological examination results will serve as the 'gold standard' for evaluating the screening efficacy of human PAX1 and JAM3 gene methylation assays (PAX1m\u002FJAM3m), HPV testing, and cytological examinations. Furthermore, the study seeks to elucidate the relationship between DNA methylation levels and persistent HPV infection, while also assessing the applicability of PAX1m\u002FJAM3m across diverse clinical settings. By focusing on alterations in DNA methylation levels within cervical exfoliated cells as the primary research trajectory, this study aspires to furnish novel insights and theoretical foundations for the prevention and management of cervical cancer, targeting PAX1m\u002FJAM3m. The ultimate objective is to facilitate the clinical implementation of an enhanced cervical cancer screening protocol, thereby addressing the deficiencies of current screening methodologies, achieving greater precision in cervical cancer screening, and effectively reducing the incidence of cervical cancer while mitigating the risks of overdiagnosis and overtreatment.",[24,25,26,27,28,29],"Cervical Cancer","DNA Methylation","Cytology","Human Papillomavirus Infection","Cervical Intraepithelial Neoplasia","Cancer Screening","NOT_YET_RECRUITING","2024-08-15",{"date":33,"type":34},"2024-08-19","ACTUAL",{"date":36,"type":20},"2024-09-01",{"date":38,"type":20},"2026-10-01",{"name":40,"class":41},"Lei Li","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":42},"100558968","exosome-based-ocs-scores-for-predicting-ovarian-cancer-recurrence-100558968","NCT06558019","Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence","Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence: a Prospective Multicenter Observational Cohort","Inclusion Criteria:\n\n* Women over 18 years old\n* Pathological diagnosis of stage I-IV epithelial ovarian cancer\n* Eastern Cooperative Oncology Group (ECOG) score ≤ 2\n* Expected survival period exceeding 6 months\n* Within 8 weeks between diagnosis and enrollment\n* Sign informed consent form\n\nExclusion Criteria:\n\n* Non epithelial ovarian tumors\n* History of cancer in the past 5 years\n* Received systematic treatment for ovarian cancer\n* Gestation\n* Previous bilateral oophorectomy",{"count":51,"type":20},509,"Ovarian cancer is the third most common malignant tumor in China's female reproductive system in terms of incidence rate and the first in terms of mortality. Surgery and systemic chemotherapy are the cornerstone of first-line treatment for patients with epithelial ovarian cancer. The efficacy rate of first-line platinum combined with taxus chemotherapy is more than 80%, and more than half of them reach complete remission (CR). However, even if advanced patients reach CR, 50% -70% still relapse, with a median disease-free interval of 16 months. Most patients lack typical symptoms when they relapse. The sensitivity of CA125 in monitoring recurrence is poor (43-74%), which means that more than 25% of ovarian cancer patients cannot detect recurrence in a timely manner during follow-up. Therefore, more sensitive biomarkers are needed for monitoring ovarian cancer recurrence after treatment. More and more studies have explored the application value of extracellular vesicle technology in the diagnosis and treatment of ovarian cancer, including auxiliary diagnosis, prognosis, monitoring, etc. China already has an approved exosome ovarian cancer diagnostic product by the National Medical Products Administration, namely the Ovarian Cancer Diagnostic Score (OCS) product based on exosome technology, which is also the world's first exosome technology diagnostic kit for ovarian cancer. Clinical trial data shows that OCS products have demonstrated excellent performance in distinguishing between benign and malignant ovarian tumors. Under high specificity (90.2%), it has a higher sensitivity than serum CA125, reaching 95.5% (95% CI 92.7% -97.3%), and has a sensitivity of 89.7% in the diagnosis of stage I ovarian cancer. OCS exhibits better sensitivity than CA125, especially in early ovarian cancer, suggesting that OCS may be a better tool for monitoring recurrence in ovarian cancer patients.The main purpose of this study is to establish an OCS scoring ovarian cancer recurrence prediction and monitoring model based on exosome technology, providing an effective tool for clinical ovarian cancer recurrence prediction and monitoring. Secondly, we hope to explore the correlation between OCS score and tumor staging, chemotherapy sensitivity, PFS, OS indicators, etc., and determine the performance of recurrence prediction models in different subgroups, such as different pathological subtypes of ovarian cancer and different treatment methods.",[54],"Ovarian Cancer",[56,57,58,59,60,61],"Ovarian cancer","Exosome","Extracellular vesicles","Cancer recurrence","Liquid biopsy","CA-125","2024-08-14",{"date":64,"type":34},"2024-08-16",{"date":66,"type":20},"2024-10-01",{"date":68,"type":20},"2026-12-31",{"name":40,"class":41},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":42},"100553884","a-multicenter-randomized-controlled-study-of-photoelectric-detection-in-cervical-cancer-screening-100553884","NCT06491888","A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening","A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.\n* 2\\. Have clear cervical cancer screening results, meet HPV16\u002F18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.\n* 3\\. Fully informed and agreed to participate in the study.\n* 4\\. No history of cervical cancer disease and cancer in other parts.\n\nExclusion Criteria:\n\n* 1\\. Cannot meet all Inclusion Criteria.\n* 2\\. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。\n* 3\\. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.","65 Years",{"count":79,"type":20},4200,"INTERVENTIONAL",[82],"NA","The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study.\n\nThe secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining.\n\nIn this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.",[85,28,86,87],"Uterine Cervical Cancer","High Grade Squamous Intraepithelial Lesions","Low Grade Squamous Intraepithelial Lesions","2024-08-13",{"date":31,"type":34},{"date":91,"type":20},"2024-08",{"date":93,"type":20},"2025-07",{"name":40,"class":41},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":42},"100553118","a-multicenter-real-world-study-of-screening-of-cervical-cancer-based-on-photoelectric-detection-100553118","NCT06481930","A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection",{"count":101,"type":20},20000,"The main purpose of this study is to explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. The secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining.\n\nThis study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, HPV nucleic acid detection and cytology detection. The advantages and disadvantages of fluorescent photoelectric cervical disease image detector, HPV nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for China's national conditions.",[85,86,87],"2024-06-30",{"date":106,"type":34},"2024-07-03",{"date":108,"type":20},"2024-07",{"date":110,"type":20},"2026-07",{"name":40,"class":41},""]